BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC GRAFT

    MDR report key: 604082 · Received May 19, 2005

    Report

    Report Number
    1820334-2005-00163
    Event Type
    Injury
    Date Received
    May 19, 2005
    Date of Event
    April 20, 2005
    Report Date
    April 21, 2005
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A VERY LONG ABDOMINAL AORTIC ANEURYSM, WITH INTERNAL ILIAC ARTERIES ORGINATING VERY CLOSE TO THE AORTIC BIFURCATION. IN ORDER TO MAINTAIN PATENCY OF THE RIGHT INTERNAL ILIAC ARTERY, THE CONTRALATERAL 1EG GRAFT WAS DEPLOYED INTO THE MAIN BODY GRAFT WITH A TWO FULL STENT BODY OVERLAP. RETROGRADE ANGIOGRAM OF THE 1EG GRAFT PLACEMENT OBSERVED PATENCY OF THE RIGHT INTERNAL ILIAC ARTERY. IPSILATERAL LEG GRAFT WAS DEPLOYED INTO THE MAIN BODY LIMB WITH A THREE AND ONE-HALF STENT BODY OVERLAP, SUPPORTING THE HIGH PLACEMENT OF THE CONTRALATERAL LEG GRAFT AND PATENCY OF THE LEFT INTERNAL ILIAC ARTERY, ZENITH GRAFT AND PATENCY OF THE LEFT INTERNAL ILIAC ARTERY. ZENITH GRAFT WAS BALLOONED AND MOLDED TO THE VESSEL WALL. FINAL ANGIOGRAM NOTED THE RIGHT INTERNAL ILIAC ARTERY HAD BEEN OCCLUDED BY THE LEG GRAFT. A SECOND LEG GRAFT WAS DEPLOYED ON THE IPSILATERAL SIDE TO FURTHER EXTEND THE SEAL INTO THE EXTERNAL ILIAC ARTERY. PROCEDURE CONCLUDED WITH NO ENDOLEAK PRESENCE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC GRAFT ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1471136

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention